Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The overall research objective of this proposal is to determine the acute and chronic impact of transcranial photobiomodulation on indices of cerebral vascular health and neurocognitive function.
Neurocognitive conditions and diseases including cognitive dysfunction, Alzheimer's disease and related dementias (ADRD) are among the fastest growing causes of morbidity and mortality. ADRDs impact > 5 million people in the United States alone and > 47 million people worldwide. The physiological reasons for these conditions are multifactorial but one contributing factor is impaired cerebral vascular function/health. Importantly, impaired cerebral vascular function/health results in cerebral hypoperfusion thereby contributing to neuronal damage and neurodegenerative processes ultimately contributing to the aforementioned neurocognitive impairments. Furthermore, it is critical to investigate therapeutic strategies to combat this elevated risk. One promising approach is Transcranial Photobiomodulation (tPBM) which is a novel and non-invasive strategy that utilizes low-level laser therapy to activate intracellular enzymatic pathways leading to an increase in mitochondrial activity, cerebral oxygenation, and thus neural and overall brain function. Importantly, this approach improves cognitive function in various animal models and limited human populations. Furthermore, there is limited evidence to suggest that these neurocognitive improvements are in-part related to increases in cerebral blood flow and cerebral vascular function/health. However, information regarding the mechanisms and effectiveness of tPBM are still relatively unknown - which represents a critical knowledge gap in the literature.
Therefore, the overall research objective is of this proposal is to determine the impact of tPBM on indices of neurocognitive and cerebral vascular health. The following objectives / aims will be explored:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcranial Photobiomodulation | Experimental | Transcranial Photobiomodulation (tPBM) is a novel and non-invasive strategy that utilizes a helmet that delivers low-level laser therapy to activate intracellular enzymatic pathways leading to an increase in mitochondrial activity, cerebral oxygenation, and thus neural and overall brain function. Importantly, this approach improves cognitive function in various animal models and limited human populations. Furthermore, there is limited evidence to suggest that these neurocognitive improvements are in-part related to increases in cerebral blood flow and cerebral vascular function/health. |
|
| Sham condition | Placebo Comparator | In this condition the participants will wear the Transcranial Photobiomodulation (tPBM) headgear; however, no light will be delivered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Photobiomodulation | Device | The transcranial photobiomodulation will be delivered through the Neuradiant 1070 Plus-Programmable 4-Quadrant Photobiomodulation System. This is a commercially available helmet that will be purchased from a commercially available source. |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral vasodilator function | This will be assessed as the increase in blood flow in the middle cerebral artery during a hypercapnic stimulus | Immediately before the start of the experimental or sham condition intervention. And immediately after the end of the experimental or sham condition intervention. |
| Neurocognitive function | This will be assessed using the NIH Toolbox which is a battery that consists of several cognitive challenges. | Immediately before the start of the experimental or sham condition intervention. And immediately after the end of the experimental or sham condition intervention. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert M Brothers, PhD | University of Texas at Arlington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Arlington - Science and Engineering Innovation and Research Building | Arlington | Texas | 76010 | United States |
No There is not a plan to share individual participant data (IPD)
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
Not provided
Not provided
Individuals will be randomly assigned either an experimental or a control condition
Not provided
Not provided
The investigators will use a randomizer to assign the participant with either the experimental or sham treatment condition.
|
| Transcranial Photobiomodulation helmet (Neuradiant 1070 Plus) with no light administered | Device | In this condition the participants will wear the Transcranial Photobiomodulation helmet (Neuradiant 1070 Plus); however, the light will not be administered. |
|
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |